BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT RETURN GROUNDING PAD

    MDR report key: 1063026 · Received June 19, 2008

    Report

    Report Number
    3005099803-2008-00783
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ODR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY WAS UNABLE TO SUPPLY THE LOT NUMBER OF THE DEVICE USED; CONSEQUENTLY, THE EXPIRATION DATE OF THE DEVICE IS UNK. USER FACILITY WAS UNABLE TO SUPPLY THE LOT NUMBER OF THE DEVICE USED, CONSEQUENTLY, THE MANUFACTURE DATE OF THE DEVICE IS UNK. THE SUSPECT DEVICE HAS BEEN RECEIVED; HOWEVER, THE DEVICE EVAL HAS NOT BEEN COMPLETED. THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE CLINICIAN WAS PERFORMING A THERAPEUTIC RADIO FREQUENCY ABLATION PROCEDURE ON A 4.5CM TUMOR IN A MALE PT. FOUR PT RETURN GROUNDING PADS WERE APPLIED TO THE PT AND THE PHYSICIAN THEN DEPLOYED THE LEVEEN NEEDLE ELECTRODE TINES FULLY AND SET THE RADIO FREQUENCY GENERATOR POWER FROM 170 WATTS TO 180 WATTS. AT THIS TIME, THE GENERATOR DISPLAYED A "P2" ERROR MESSAGE. THE CONNECTIONS WERE CHECKED AND THE GENERATOR WAS RESET. THE RADIO FREQUENCY GENERATOR POWER WAS AGAIN SET FROM 170 WATTS TO 180 WATTS, BUT THE "P2 ERROR MESSAGE WAS AGAIN DISPLAYED AND ROLL-OFF WAS NOT ACHIEVED. THE TINES OF THE LEVEEN NEEDLE ELECTRODE WERE THEN SLIGHTLY RETRACTED BY THE CLINICIAN AND ROLL-OFF WAS ACHIEVED. THE COMPLAINANT REPORTED THAT THERE WAS NO ADVERSE AFFECT TO THE PT AS A RESULT OF THE REPORTED MALFUNCTION. PLEASE REFERENCE MFR. REPORT NUMBERS 3005099803-2008-00781, 3005099803-2008-00784 AND 3005099803-2008-00782 THAT REPORT THE REPORTED PROBLEM THAT OCCURRED WITH PT RETURN GROUNDING PADS 1, 2 AND 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT RETURN GROUNDING PAD GROUNDING PAD ODR BOSTON SCIENTIFIC CORPORATION 26-219 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK